title: Pharmacology and toxicology of an oral tablet whole cells inactivated cholera vaccine in Sprague Dawley rats.
abstract: Here we further investigate the pharmacological and toxicological properties of a cholera vaccine based on inactivated whole cells presented in either enteric coated (COA) or uncoated (U/C) tablet formulation from Vibrio cholerae C7258 strain. Tablets were dispersed in 2mL drinking water and administered orally to Sprague Dawley rats distributed in five groups (I COA7, II U/C7 immunized at 0, 7, 69days and III COA14, IV U/C14 immunized at 0, 14, 69days and V control group). Serum vibriocidal antibody response was measured after the administration of two doses with an interval of 7-14days. To further investigate the toxicological aspects a third dose was applied 10 weeks after the initial one. Animals were observed daily and water and food consumption was measured every other day. Periodic blood extractions were performed for hematology, biochemistry, and the titer of serum vibriocidal antibodies was determined. Anatomopathological analysis was performed at days 3 or 14 after the third dose. Results from clinical observations, as well as from water and food consumption and body weigh indicated no toxicity of the vaccine product. Meanwhile, no biological differences were found among different groups in hematological, hemo-chemistry, and anatomopathological studies. Moreover, enteric coated and uncoated tablets against human cholera were found to induce an immune response in rats.
authors.affiliation: Finlay Institute, Center for Research-Production of Vaccines, 27th Ave. No. 19805, La Lisa, Ciudad de la Habana 11600, Cuba.
authors.forename: Yulieé
authors.initials: Y
authors.lastname: López
authors.forename: Juan Francisco
authors.initials: JF
authors.lastname: Infante
authors.forename: Sergio
authors.initials: S
authors.lastname: Sifontes
authors.forename: Daiyana
authors.initials: D
authors.lastname: Díaz
authors.forename: Viviana
authors.initials: V
authors.lastname: Pérez
authors.forename: Gemma
authors.initials: G
authors.lastname: Año
authors.forename: Tamara
authors.initials: T
authors.lastname: Hernández
authors.forename: Sonsire
authors.initials: S
authors.lastname: Fernández
authors.forename: Jorge Luis
authors.initials: JL
authors.lastname: Castaño
authors.forename: Bárbara
authors.initials: B
authors.lastname: Cedré
authors.forename: Reynaldo
authors.initials: R
authors.lastname: Oliva
authors.forename: Luis
authors.initials: L
authors.lastname: García
authors.forename: Rosa L
authors.initials: RL
authors.lastname: Solís
authors.forename: Arturo
authors.initials: A
authors.lastname: Talavera
mesh_terms: D000284:Administration, Oral; D000818:Animals; D000907:Antibodies, Bacterial / Q000097:blood; D002771:Cholera / Q000517:prevention & control*; D022121:Cholera Vaccines / Q000276:immunology* / Q000633:toxicity; D005260:Female; D007114:Immunization; D008297:Male; D023421:Models, Animal; D051381:Rats; D017207:Rats, Sprague-Dawley; D013607:Tablets; D015164:Vaccines, Inactivated / Q000276:immunology / Q000633:toxicity; D014734:Vibrio cholerae / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D022121:Cholera Vaccines; D013607:Tablets; D015164:Vaccines, Inactivated